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AREDIA DRY POWDER 30MG

Active substance(s): PAMIDRONATE DISODIUM ANHYDROUS

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5. How to store Aredia
6. Further information
1. What Aredia is and what it’s used for
The Aredia pack includes vials containing
DRY POWDER the Aredia powder, and ampoules
containing Water for Injections. These are
15, 30 and 90 mg
used to make up the injection solution.
(pamidronate disodium)
The active ingredient in Aredia is called
pamidronate disodium. This is one of a
group of medicines called bisphosphonates
Patient Information Leaflet
which can help to regulate the amount of
calcium in the blood.
What you need to know about Aredia Dry
High blood calcium levels (hypercalcaemia)
Powder
occur in a number of conditions, including
Your doctor has decided that you need this
some types of cancer. Often,
medicine to help treat your condition.
hypercalcaemia is caused by the release of
Please read this leaflet carefully before
calcium from bones. Aredia sticks to bones
you start to take your medicine. It
and helps to reduce the release of calcium
contains important information. Keep the into the blood. If untreated, hypercalcaemia
leaflet in a safe place because you may want can cause symptoms such as nausea,
to read it again.
tiredness and confusion.
If you have any other questions, or if there is
Aredia is used to treat high blood calcium
something you don’t understand, please ask
levels caused by some cancers. In some
your doctor or pharmacist.
patients with cancer, it is also used to treat
If any of the side effects gets serious, or if
bone disease and to help relieve bone pain.
you notice any side effects not listed in this
Aredia is also used to treat Paget’s disease.
leaflet, please tell your doctor or
pharmacist.
2. Things to consider before you take
This medicine will usually be referred to
Aredia
just as Aredia in this leaflet.
Some people MUST NOT take Aredia.
Talk to your doctor if:
In this leaflet:
▯▯ you think you may be allergic to Aredia or
1. What Aredia is and what it’s used for
any other bisphosphonate, or to the other
2. Things to consider before you start to
ingredients of Aredia powder (these are
take Aredia
listed at the end of the leaflet).
3. How to take Aredia
4. Possible side effects
Aredia is not suitable for treating children.

AREDIA®

You should also ask yourself these
questions before taking Aredia:
▯▯ Do you suffer from any kidney disease?
▯▯ Do you suffer from any heart problems?
▯▯ Do you have any liver problems?
▯▯ Have you ever had thyroid problems?
▯▯ Are you likely to suffer from calcium or
Vitamin D deficiency?
▯▯ Have you had any problems with your
teeth or jaw?
▯▯ Are you suffering from a feverish illness
e.g. flu or something similar?
▯▯ Are you pregnant or breastfeeding?
If the answer to any of these questions
is YES, tell your doctor or nurse because
Aredia might not be the right medicine
for you.
Are you taking other medicines?
Some medicines can interfere with your
treatment. Tell the doctor or nurse if you
are taking any of the following:
▯▯ Other medicines for high calcium levels
such as calcitonin
▯▯ Other bisphosphonates
▯▯ Other medicines that may affect the
kidneys (Your doctor or nurse will know
which drugs these are.)
▯▯ Thalidomide (used to treat some
cancers).
Always tell your doctor about all the medicines
you are taking. This means medicines you
have bought yourself as well as medicines on
prescription from your doctor.
Other special warnings
▯▯ Visiting the dentist:
▯▯ Because treatment with Aredia may
affect your jaw bone, you must make

▯▯

▯▯

▯▯

sure that your dentist knows that you
are having Aredia before you have any
dental treatment or surgery.
▯▯ Go to the dentist before you start your
treatment.
▯▯ The dentist should avoid invasive
dental procedures during treatment
with Aredia.
▯▯ Make sure you are careful with your
dental hygiene and go to the dentist
regularly throughout your Aredia
treatment.
You must make sure that you do not
become dehydrated while you are being
treated with Aredia. Talk to your doctor
to make sure you are aware how much
you must drink.
Whilst you are being treated with Aredia,
your doctor will want to check your
progress by carrying out a number of
tests e.g. blood tests and kidney function
tests. Remind your doctor you are taking
Aredia before he/she does any tests.
Aredia may affect the results.
Pregnancy and breastfeeding:
▯▯ If you are pregnant, your doctor should
not prescribe Aredia to you except in
cases of life-threatening
hypercalcaemia.
▯▯ Breastfeeding during therapy with
Aredia is not recommended.

Will there be any problems with driving
or using machinery?
If you feel sleepy or dizzy after being treated
with Aredia, do not drive or use machinery
until these effects wear off.

3. How to take Aredia
Your doctor will have decided on the right
dose depending on your condition.
A doctor or nurse will prepare the injection
by dissolving Aredia powder in the water
provided and then diluting this solution
with a special infusion fluid. The made-up
solution must be stored in a refrigerator
and used with 24 hours.
Aredia is given by very slow injection into a
vein (intravenous infusion). The infusion
will take from one to several hours
depending on the dose. Your doctor will
decide how many infusions you need and
how often they will be given.
Dosage guidelines are as follows:
For hypercalcaemia
15-90 mg given as a single or several
infusions.
For bone diseases and bone pain
90 mg every 4 weeks. In some patients the
dose may be given every 3 weeks at the
same time as chemotherapy.
For Paget’s disease
180 to 210 mg given as either 30 mg once a
week for 6 weeks, or 60 mg every other
week for 6 weeks.
Your doctor may also give you a test dose
of 30 mg to see how you respond to the
treatment.
Your doctor may also have prescribed
treatment with Calcium and Vitamin D
at the same time as Aredia.

For the Medical and Pharmaceutical
Professions
Administering Aredia

preferable to use the product immediately
after aseptic reconstitution and dilution.
If not used immediately, the duration and
conditions of storage prior to use are the
care provider’s responsibility. The total
time between reconstitution, dilution and
storage in a refrigerator at 2 to 8°C and end
of administration must not exceed 24 hours.

In order to minimise local reactions at the
infusion site, the cannula should be inserted
carefully into a relatively large vein.

Tumour-induced hypercalcaemia
Patients must be adequately rehydrated,
using 0.9% w/v sodium chloride solution,
prior to and during administration of Aredia.
The total dose of Aredia to be used for a
Therapeutic indications
treatment course depends on the patient's
Treatment of conditions associated with
initial serum calcium levels. The following
increased osteoclast activity:
guidelines are derived from clinical data on
▯▯ Tumour-induced hypercalcaemia
uncorrected calcium values. However, doses
▯▯ Osteolytic lesions and bone pain in
within the ranges given are also applicable
patients with bone metastases associated for calcium values corrected for serum
with breast cancer or multiple myeloma
protein or albumin in rehydrated patients.
▯▯ Paget's disease of bone.
Table 1
Posology and method of administration
Initial serum calcium
Recommended
Aredia must never be given as a bolus
Incompatibilities
total
injection
(see
SmPC
Section
4.4).
The
Studies with glass bottles, as well as
reconstituted solution of Aredia from
(mmol/L) (mg %)
dose (mg)
infusion bags made from polyvinylchloride
powder in vials should be diluted in a
and polyethylene (prefilled with 0.9% w/v
up to 3.0 up to 12.0 15 - 30
calcium-free infusion solution (0.9 % w/v
sodium chloride solution or 5% w/v
12.0 - 14.0 30 - 60
3.0 - 3.5
sodium
chloride
solution
or
5%
w/v
glucose solution) showed no incompatibility
14.0 - 16.0 60 - 90
3.5 - 4.0
glucose
solution)
and
infused
slowly.
with Aredia.
90
> 16.0
> 4.0
The infusion rate should not exceed 60 mg/
To avoid potential incompatibilities, Aredia
The total dose of Aredia may be
hour
(1 mg/min),
and
the
concentration
of
reconstituted solution is to be diluted with
administered either in a single infusion or in
Aredia in the infusion solution should not
0.9% w/v sodium chloride solution or 5%
multiple infusions over 2 to 4 consecutive
exceed
90 mg/250 ml.
A
dose
of
90 mg
w/v glucose solution. Aredia reconstituted
days. The maximum dose per treatment
should
normally
be
administered
as
a
solution must not be mixed with calciumcourse is 90 mg for both initial and repeated
containing solution such as Ringer’s solution. 2-hour infusion in 250 mL infusion solution. courses.
However, in patients with established or
Special precautions for storage
suspected renal impairment (e.g. those with A significant decrease in serum calcium is
tumour-induced hypercalcaemia or multiple generally observed 24 to 48 hours after
Protect vials from heat (store below 30°C).
The reconstituted solution is chemically and myeloma) it is recommended that the
administration of Aredia, and normalisation
infusion rate does not exceed 90 mg in
physically stable for 24 hours at room
is usually achieved within 3 to 7 days. If
500 mL over 4 hours (see also SmPC
temperature. However, from a
normocalcaemia is not achieved within this
Section 4.2).
microbiological point of view, it is
2119552  GB
Instructions for use and handling
Powder in vials should be first dissolved in
sterile water for injection, i.e. 15 mg in
5 mL. The sterile water for injection is
available in ampoules which are supplied
together with vials. The pH of the
reconstituted solution is 6.0-7.0. The
reconstituted solution should be further
diluted with a calcium-free infusion solution
(0.9% w/v sodium chloride or 5% w/v
glucose solution) before administration. It
is important that the powder be completely
dissolved before the reconstituted solution
is withdrawn for dilution.

Proof 3

2119552_GB.indd 1

Leaflet_AREDIA_15MG+30MG+90MG _GB
2119552_GB
Novartis
2103592_GB
Order File
GB
799338_SB
2119552
contract manufacturer:
420 x 148 mm
Stein
800.4.9009/03
Page 1 of 2
Sec. Edge Marks N/A
Typopharma # 106318

Product
Material No.
Replaced No.
Country
Code No.
Dimension
Drawing No.

08.07.13 16:47:53

Stein_420x148_128auto
Novartis Pharma Stein AG
Fontsize
8,7 pt / 9 pt / 100 %
technical
6 pt
Used Font NewsGothicTP-Cond.
NewsGothicMT Pro
Colours
Black
additional Cutting / Dimensions
Perforating

1. proof
2. proof
3. proof
4. proof
5. proof
6. proof

10.06.2013 kh
03.07.2013 kh
08.07.2013 sw

TVT compatible
yes
no

X

Perforationslinie
ist variabel je
nach Textmenge

time, a further dose may be given. The
duration of the response may vary from
patient to patient, and treatment can be
repeated whenever hypercalcaemia recurs.
Clinical experience to date suggests that
Aredia may become less effective as the
number of treatments increases.
Predominantly lytic bone metastases and
multiple myeloma
The recommended dose of Aredia for the
treatment of predominantly lytic bone
metastases and multiple myeloma is 90 mg
administered as a single infusion every
4 weeks.
In patients with bone metastases who
receive chemotherapy at 3-weekly intervals,
Aredia 90 mg may also be given on a
3-weekly schedule.
Paget's disease of Bone
The recommended treatment course
consists of a total dose of 180 to 210mg
administered in unit doses of either 30 mg
once a week for 6 consecutive weeks, or
60 mg every other week over 6 weeks.
Experience to date suggests that any mild
and transient unwanted effects (see SmPC
Section 4.8) tend to occur after the first
dose. For this reason if unit doses of 60 mg
are used it is recommended that treatment
be started with an initial dose of 30 mg
followed by 60 mg every other week (i.e.
total dose 210 mg). Each dose of 30 or
60 mg should be diluted in 125 or 250 ml
0.9% w/v sodium chloride solution
respectively, and the infusion rate should
not exceed 60 mg/hour (1 mg/min). This
regimen or increased dose levels according

to disease severity, up to a maximum total
dose of 360 mg (in divided doses of 60 mg)
can be repeated every 6 months until
remission of disease is achieved, and if
relapse occurs.

(creatinine clearance 61-90 mL/min) to
moderate renal impairment (creatinine
clearance 30-60 mL/min). In such patients,
the infusion rate should not exceed
90 mg/4h (approximately 20-22 mg/h).

Renal Impairment
Aredia should not be administered to
patients with severe renal impairment
(creatinine clearance < 30 mL/min) unless
in cases of life-threatening tumour-induced
hypercalcaemia where the benefit outweighs
the potential risk. Because there is only
limited clinical experience in patients
with severe renal impairment no dose
recommendations for this patient population
can be made (see SmPC Section 4.4 and
5.2).
As with other i.v. bisphosphonates, renal
monitoring is recommended, for instance,
measurement of serum creatinine prior to
each dose of Aredia. In patients receiving
Aredia for bone metastases or multiple
myeloma who show evidence of
deterioration in renal function, Aredia
treatment should be withheld until renal
function returns to within 10% of the
baseline value. This recommendation is
based on a clinical study, in which renal
deterioration was defined as follows:
▯▯ For patients with normal baseline
creatinine, increase of 0.5 mg/dL.
▯▯ For patients with abnormal baseline
creatinine, increase of 1.0 mg/dL.
A pharmacokinetic study conducted in
patients with cancer and normal or impaired
renal function indicates that the dose
adjustment is not necessary in mild

Hepatic impairment
Although patients with hepatic impairment
exhibited higher mean AUC and Cmax
values compared to patients with normal
hepatic function, this is not perceived as
being clinically relevant. As pamidronate is
still rapidly cleared from the plasma almost
entirely into the bone and as it is
administered on a monthly basis for chronic
treatment, drug accumulation is not
expected. Therefore no dose adjustment is
necessary in patients with mild to moderate
abnormal hepatic function (see SmPC
Section 5.2). Clinical data in patients with
severe hepatic impairment is not available
(see SmPC Section 4.4). Pamidronate
should be administered to this patient
population with caution.
Children
There is no clinical experience with Aredia
in children. Therefore until further
experience is gained, Aredia is only
recommended for use in adult patients.

What if you have had too much Aredia?
(Overdose)
If you think you have either been given or
have taken too much Aredia tell your doctor
or nurse straight away. If you think you
have either been given it or have taken it
too often, also tell your doctor or nurse
straight away.
What if you miss a dose of Aredia?
If you miss one of your appointments,
please let your doctor or nurse know
immediately.
4. Possible side effects
Aredia is suitable for most people, but, like
all medicines, it can sometimes cause side
effects. The side effects are usually mild
and disappear as treatment continues. It is
sometimes not clear whether the symptoms
are related to your illness or to your
treatment.
A very common effect is a mild fever with
flu like symptoms such as sore throat,
shivering, high temperature or hot flushes,
which occur at the start of treatment and
last for 24-48 hours.
Some patients notice an increase in bone
pain soon after starting treatment. This
usually improves after a few days. If it
does not, tell your doctor.
Unusual fracture of the thigh bone
particularly in patients on long-term
treatment for osteoporosis may occur.
Contact your doctor if you experience pain,
weakness or discomfort in your thigh, hip
or groin as this may be an early indication
of a possible fracture of the thigh bone.

Some side effects can be serious
Tell the doctor straight away if you notice:
Bronchospasm with wheezing or
coughing and difficulty in breathing,
or swelling of your face, lips or hands.
▯▯ If you feel faint (you might have low
blood pressure), have a rash, or
experience itching or facial swelling.
These might be the result of an allergic
reaction which is very rare (likely to affect
fewer than 1 in 10,000 patients).
▯▯

The side effects listed below have also
been reported.
Up to 1 in 10 people have experienced:
▯▯ Pain, redness or swelling at the infusion
site
▯▯ Skin rash or unexplained bruising/
increased bleeding
▯▯ Joint or muscle pain
▯▯ Nausea, vomiting, loss of appetite,
stomach pain, gastritis, constipation or
diarrhoea
▯▯ Headache, sleeplessness, tiredness
▯▯ Conjunctivitis
▯▯ Tingling in hands and feet and muscle
spasms (symptoms of low level of
calcium)
▯▯ High blood pressure
▯▯ Low level of white blood cells
(leucopenia) or red blood cells (anaemia)
▯▯ Changes in blood test results (including
low potassium, low phosphate, low
magnesium and raised serum creatinine
levels or, very rarely, raised potassium or
sodium levels)
▯▯ Irregular heart rhythm.

Up to 1 in 100 people have experienced:
Generalised pain
Muscle cramps
Dizziness, lethargy, feeling agitated,
seizures
▯▯ Problems with vision, painful red eyes
▯▯ Low blood pressure
▯▯ Itching, indigestion
▯▯ Deterioration of kidney function (e.g.
unexpected change in the amount of
urine produced and/or its appearance),
abnormal liver function tests or increases
in serum urea
▯▯ Problems with teeth, jaw, or bones.
▯▯
▯▯
▯▯

Patients taking Aredia have also
reported experiencing the following:
▯▯ Shortness of breath, respiratory failure
▯▯ Severe and occasionally incapacitating
bone, joint and/or muscle pain
▯▯ Renal disorders.

5. How to store Aredia
The vials of Aredia powder before they are
made up into the injection should be stored
below 30°C. The made-up solution must be
stored in a refrigerator and used with
24 hours.
Any unused solution should be thrown away.
Up to 1 in 1,000 people have
Keep out of the reach and sight of children.
experienced:
Do not use Aredia after the expiry date
A change in kidney function known as
which is printed on the outside of the pack.
glomerulosclerosis, some of the symptoms
If your doctor tells you to stop taking Aredia
of this condition may be, fluid retention,
and you have been keeping some at home,
nausea and fatigue. Tell your doctor if you
suspect that you might have these symptoms please take any unused vials back to your
pharmacist to be destroyed. Do not throw
Up to 1 in 10,000 people have
them away with your normal household
experienced:
water or waste. This will help to protect
▯▯ Cardiac or respiratory effects which may
the environment.
include a difficulty in breathing and fluid
6. Further information
retention
Aredia is available in clear glass vials
▯▯ Changes in kidney function, including
worsening of an existing kidney problem containing either 15, 30, or 90 mg of
pamidronate disodium powder. The vials
e.g. blood in urine
also contain the inactive ingredients
▯▯ A flare-up of cold sores or shingles
mannitol and phosphoric acid.
▯▯ Confusion or visual hallucinations
(seeing things that are not there)
Aredia packs contain 1, 2 or 4 vials of
▯▯ Painful and/or swollen eye.
powder. Each pack also contains 1 ampoule
of water (5 ml ampoules for 15 and 30 mg
If any of the symptoms described above
vials and 10 ml ampoules for 90 mg vials)
become troublesome, or if you notice
anything else not mentioned here, please for every Aredia vial.
Not all of the pack sizes are marketed.
go and see your doctor.

The product licence holder is Novartis
Pharmaceuticals UK Limited, trading as
Ciba Laboratories, Frimley Business Park,
Frimley, Camberley, Surrey, GU16 7SR,
England.
The manufacturer responsible for the
release on to the market is Novartis
Pharmaceuticals UK Limited, Wimblehurst
Road, Horsham, West Sussex RH12 5AB,
England or Novartis Pharmaceuticals UK
Limited, Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, United
Kingdom.
This leaflet was revised in 07/2013.
If you would like any more information, or
would like the leaflet in a different format,
please contact Medical Information at
Novartis Pharmaceuticals UK Ltd,
telephone number 01276 698370.
AREDIA is a registered Trade Mark
Copyright Novartis Pharmaceuticals UK
Limited

2119552  GB

proof 3

2119552_GB.indd 2

Leaflet_AREDIA_15MG+30MG+90MG _GB
2119552_GB
Novartis
2103592_GB
Order File
GB
799338_SB
2119552
contract manufacturer:
420 x 148 mm
Stein
800.4.9009/03
Page 2 of 2
Sec. Edge Marks N/A
Typopharma # 106318

Product
Material No.
Replaced No.
Country
Code No.
Dimension
Drawing No.

08.07.13 16:47:53

Stein_420x148_128auto
Novartis Pharma Stein AG
Fontsize
8,7 pt / 9 pt / 100 %
technical
6 pt
Used Font NewsGothicTP-Cond.
NewsGothicMT Pro
Colours
Black
additional Cutting / Dimensions
Perforating

1. proof
2. proof
3. proof
4. proof
5. proof
6. proof

10.06.2013 kh
03.07.2013 kh
08.07.2013 sw

TVT compatible
yes
no

X

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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